FAQ

Latex Fun Facts

1. If you took all the gloves consumed in the U.S. in one year (20 billion) and laid them end to end, you could circle the earth 116 times! (And thats without stretching them!)

2. Dr. William Halstead ordered the first dipped latex gloves for his nurse with severely chapped hands at John Hopkins Hospital in 1889.

3. Raw latex is harvested from the Havea brasiliensis tree (rubber tree) one drop at a time in a process very similar to maple syrup.

4. In 1777, pencil marks were first "rubbed" out, hence the name "rubber".

5. In 1823, rubber was poured on fabric for the first waterproof raingear.

Natural Rubber Latex gloves currently represent the best option for most healthcare practitioners by combining excellent barrier protection, comfort and a reasonable price. It makes sense to use powder-free latex gloves whenever possible due to their lower levels of latex protein when compared to powdered latex gloves. A high quality powder-free latex exam glove will help reduce the incidence of skin irritations. However for individuals who are suspected or confirmed to have a true Type I hypersensitivity to latex, any type of latex glove is unacceptable. For these individuals, non-latex gloves are the best alternative. Vinyl (commonly referred to as synthetic) or nitrile gloves are good choices. Vinyl gloves are appropriate for light duty, general purpose applications. Vinyl is not as durable and therefore not as good of a long-term barrier as latex. For more physically demanding applications, nitrile is a better non-latex glove choice. Nitrile has exceptional barrier properties but is not as stretchy as latex, and it does cost slightly more than latex at the present time.

Accelerator : Chemicals added during the manufacturing process to control the physical properties of the latex. Accelerators include thiurams and carbamates.

AQL : Acceptable Quality Level. Statistical measure of total defects allowed per 100 gloves. Current exam glove AQL is required by the FDA is 2.5. Digitcare strives on having an AQL at 1.0 or lower for most of its gloves. AQL includes both barrier and visual defects.

ASTM : Acronym for American Society of Testing Materials. This is a volunteer organization which establishes standards for consumer and industrial goods. The FDA elected to adopt ASTM D3578-95 for rubber examination gloves as the minimum standard all medical non-sterile gloves must meet.

Elongation : Defined as “how much did the glove stretch before its breaking point.” Stronger gloves tend to stretch more before they break. FDA requirements are a minimum of 700% on an unaged glove and 500% on an aged glove.

FDA : Acronym for Food & Drug Administration. FDA started regulating the quality of gloves in 1989. Prior to that year, gloves were exempt from any FDA regulation, including non-requirement of 510K Premarket notifications from manufacturers.

FDA 1000 ml watertight test : FDA approved method to determine the number of pinholes per 100 gloves. Gloves are actually suspended from a cylinder column and filled with a liter of water. Gloves are then manipulated by hand for 2 minutes and any leakage or pinholes are recorded as a defect.

ISO 9001: 2008 : ISO 9001: 2008 is an international quality management designation that recognizes the highest standard of manufacturing excellence in terms of process control and Total Quality Management. Achievement of ISO 9001: 2008 provides glove endusers the assurance that the final product will be of the highest quality possible. An independent party must certify ISO 9001: 2008 facilities.

Latex Protein : Naturally occurring component of Natural Rubber Latex. Latex protein is a known allergen for some people.

mm to mil conversion : ASTM standards state measurements in millimeters (mm) as do glove manufacturers. Yet endusers are more familiar with glove thickness expressed in mils, which is 1000th of an inch. To convert mm to mils, divide mm by 0.0254. ASTM / FDA minimum requirements for examination glove thickness is 0.08 mm or 3.1 mils.

Modulus : This measures the intermediate tensile strength. The FDA does not state any requirements on tensile modulus. The lower the modulus, the softer and stretchier a glove is. A lower modulus also means the tensile strength of the glove is poorer.

Pinhole Rate : Glove quality term indicating the number of barrier defects per 100 gloves. A better qualitative measure is AQL, Acceptable Quality Level. (see definition above)

Process Control : Establishes manufacturing tolerances throughout the production process with statistical validation of the process. Variances outside acceptable parameters are identified as they occur in a “real-time” frame, thus allowing for immediate process adjustments, preventing unacceptable production output or accumulated errors.

Quality Assurance : Improved quality technique that verifies quality and prevents problems throughout the manufacturing process.

Quality Control : A conventional method of inspecting quality post-production. A less desirable quality technique since problems have already occurred when detected.

Tensile Strength : Defined as the “load on specimen glove when it breaks divided by the cross section of the area.” Stated in lbs/square inch (psi). FDA requirements are a minimum of 3043 psi or 21 MPa before aging, 2319 psi or 16 MPa after aging. This is a measurement of how strong a glove is when stretched. The heavier the weight used to break the cross-sectional area, the stronger the glove is.

Type I or Immediate hypersensitivity : Immunological response to the latex proteins in latex. Potentially most serious reaction; requires immediate medical attention.

Type IV hypersensitivity : A delayed allergic reaction to residual chemicals used in the manufacture of gloves. This reaction is not life threatening.

Latex Allergy Questionaire

1. Have you ever had allergies, asthma, hay fever, eczema, or problems with rashes?

2. Have you ever had strong allergic reactions (anaphylaxis) or other unexplained reactions during a medical procedure?

3. Have you ever had swelling, itching or hives on your lips or around your mouth after blowing up a balloon?

4. Have you ever had swelling, itching or hives on your lips or around your mouth after a dental exam or procedure?

5. Have you ever had swelling, itching or hives following a vaginal or rectal exam or after contact with a diaphragm or condom?

6. Have you ever had swelling, itching or hives on your hands during or within one hour of wearing rubber gloves?

7. Have you ever had a rash on your hands which lasted longer than 1 week?

8. Have you ever had swelling, itching, or hives after being examined by someone wearing rubber or latex gloves?

9. Have you ever had swelling, itching, hives, runny nose, eye irritation, wheezing or asthma after contact with any latex or rubber product?

10. Has a physician ever told you that you have rubber or latex allergy?

11. Are you allergic to bananas, avocados or chestnuts?

If the answer is “YES” to any of the above, discontinue using latex gloves until you have consulted with your doctor.

NFPA® 1999, 2008 edition TESTING FEATURES :

•  Standard on Protective Garments for Emergency Medical Operations, Testing in general more vigorous than FDA

•  Glove Design, Class 1 Device

•  Liquid Tight Integrity AQL 1.5 vs FDA 4 : NFPA is stricter

•  Bacteriophage Permeation : Tests glove as an effective barrier against bacteria and virus. This is an advanced test not required by the FDA.

•  Tensile Strength Before & After Aging : Essentially a measure of how strong the glove is. Glove samples shall have an average ultimate tensile strength of not less that 14 Mpa (2000 psi) in both the as received condition and after heat aging.

•  Ultimate Elongation Before & After Aging & After Immersion in Isopropanol (alcohol): Looks at how much the glove stretches before breaking. Aging simulates the effects of storage and time on the performance of the glove. Alcohol immersion, unique to NFPA, simulates chemical exposure.

•  Ultimate Elongation After Isopropanol Degradation: Glove samples shall have an average ultimate elongation of not less that 500 Percent. Tensile modulus looks at glove physical characteristics, softness, stretchiness and strength. NFPA only.

•  Puncture Resistance of not less than 1 pound: Another NFPA only test looking at resistance to punctures.

•  Dexterity : Looks at gloves touch and feel characteristics.

•  Protein Content not greater than 50 microgram/gram. FDA requires protein labeling, but not a maximum level.

NFPA® 2008 testing represents a rigorous set of quality tests designed by the National Fire Protection Association. NFPA® is an independent organization that creates scientifically based consensus codes and standards designed to reduce the worldwide burden of fire. The NFPA® 2008 standards exceed the qualitative requirements as specified by the FDA and ASTM, the two traditional quality references for gloves. There are many medical gloves sold in the marketplace that can meet FDA and ASTM requirements that will not meet NFPA® requirements.

Digitcare® is proud to offer numerous gloves that meet NFPA® 2008 requirements: BarrierMax, BlackMax, DigitSafety HaloKote, HaloKote Chemotherapy, ICU911, XTG10, FrontLine 9 & 12 and Defender 10 & 12.